FDA

Dear Research Advocate: The omnibus appropriations bill about to become law demonstrates that bipartisanship and pseudo -regular order is achievable. We won’€™t know for sure if we have true ’€œregular order’€ until Congress proceeds through the FY15 appropriations process in a timely manner ’€” something that hasn’€™t happened for many years. The importance of regular order is that the public’€™s interests are heard from in hearings, and every Member of Congress participates in priority-setting instead of only having the opportunity to cast a single up-or-down vote. Regular order is worth working toward, since at least one priority we all care about did not fare well in the omnibus. The...
We applaud portions of the omnibus bill that support the nation’s research, innovation and public health ecosystem, which works to assure our future health and economic well-being. The growth in funding for the Food and Drug Administration, fueled in part by the common-sense return of the 2013 user fees, as well as the increases for the Centers for Disease Control and Prevention, the Agency for Healthcare Research and Quality and the National Science Foundation are welcome news. But funding for the National Institutes of Health has been kept well below the level of scientific opportunity. We must eliminate sequestration once and for all, and grow our investment in NIH in order to slow and...
Dear Research Advocate: Here’€™s a holiday surprise! I am not referring to the budget deal, but to the fact that Merriam-Webster’€™s 2013 word of the year ’€” determined via the greatest increase in online searches ’€” is “science.” I find this to be refreshing news, providing evidence that interest in science is growing, which in turn is an indication of substantial room for researchers and research advocates to contribute to public understanding and support of science. We appear to have an opportunity ready for the taking to overcome the “invisibility” problem that contributes to holding decision makers back from assigning a higher priority to science. And speaking of those decision...
Dear Research Advocate: As I’€™m sure you’€™ve heard, the Joint Budget Committee released a two-year budget agreement Tuesday night. The package involves $63 billion in partial sequestration relief over two years, offset by fees (not taxes!) and a wide variety of cost-sharing arrangements, AKA ’€œpay fors.’€ While it remains unclear whether user fees will be subjected to any sequester in 2014 and 2015, the already-sequestered FDA user fees are locked up and cannot be used to accelerate medical advances. This is a missed opportunity that patients can’€™t afford. While not a perfect deal in many respects, the House is expected to approve the Murray-Ryan budget deal within moments, and the...
To protect medical and health research, policy makers must eliminate sequestration. This remains Research!America’€™s top-line message, because it is sequestration that poses the greatest threat to all discretionary funding, including medical and health research conducted by NIH, CDC, FDA, NSF, AHRQ, DOD ’€¦ and the list goes on. Advocates for medical and health research have made a huge impact over the years on funding and policies supportive of medical and health research, including playing a key role in reducing sequestration in 2013. We are asking you to weigh in again to help address sequestration in FY14 and FY15. On Wednesday, the co-chairs of the committee charged with establishing...
To address the recent meningitis outbreak at Princeton, public health programs from all levels got involved. Students sought medical attention at the university’€™s health center and their hometown local hospitals; the New Jersey Department of Health (NJDOH) investigated the outbreak and requested CDC involvement; the FDA examined the case and allowed a new vaccine, unlicensed in the US but approved in Europe and Australia. With final CDC approval, the university will offer the vaccine on campus and cover the cost for all students. Diverse institutions within our public health infrastructure came together to address the outbreak, and the public health professionals within them did what was...
Urge your Members to protect medical research in upcoming Budget Conference Committee discussions Sequestration’€™s arbitrary, across-the-board budget cuts to defense and non-defense spending have ravaged (and will continue to ravage) our research enterprise. The Budget Conference Committee, which was negotiated as part of reopening the government and preventing the U.S. from defaulting on debts, has an opportunity to replace sequestration as they develop their ’€œlong-term budget solution’€ by December 13. Sequestration is rendering it virtually impossible to maintain, much less increase the budgets of NIH, NSF, FDA, and CDC; if it is not stopped, their budgets will almost certainly...
Bart Peterson, JD, Senior Vice President for Corporate Affairs and Communications at Eli Lilly , and the keynote speaker of the Research!America’s National Research Health Forum talked with Medscape about the future of research and drug development, and whether cooperation between industry and the US Food and Drug Administration (FDA) can ever truly exist. To see the interview, click here .
By Robert J. Hariri, MD, PhD, Chairman, Founder and Chief Scientific Officer of Celgene Cellular Therapeutics . Medical innovation is the source of dramatic improvements in the quality and length of life and also creates enormous value for society and the economy at large. For example, in 1900, the average U.S. life expectancy was 49 years. Today, it is 79. It is estimated by 2040, U.S. life expectancy will reach 85 years. This is primarily the result of innovation in medicine and improvements to public health. New medical treatments accounted for 45 percent of the increase in U.S. life expectancy between 1960 and 1997 and for nearly three-quarters of the increase in U.S life expectancy in...
By Robert J. Hariri, MD, PhD, Chairman, Founder and Chief Scientific Officer of Celgene Cellular Therapeutics . Medical innovation is the source of dramatic improvements in the quality and length of life and also creates enormous value for society and the economy at large. For example, in 1900, the average U.S. life expectancy was 49 years. Today, it is 79. It is estimated by 2040, U.S. life expectancy will reach 85 years. This is primarily the result of innovation in medicine and improvements to public health. New medical treatments accounted for 45 percent of the increase in U.S. life expectancy between 1960 and 1997 and for nearly three-quarters of the increase in U.S life expectancy in...

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If concerted, long-term investments in research are not made, America will lose an entire generation of young scientists.
Brenda Canine, PhD; McLaughlin Research Institute, Montana